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Information Details
New Polymer Substance Registration Series-Registration
Release time:
2021-05-12 09:56
In accordance with the "New Chemical Substances Environmental Management Registration Measures" and "New Chemical Substances Environmental Management Registration Guidelines" requirements, polymers as a special type of polymer substances, because of their own may cause less harm, registration conditions and general substances Different, and in most cases there are different degrees of data relief.
In the previous issue, we introduced the situation and exclusion conditions for resolving polymer filings. In this issue, we continue to launch the second of the polymer registration detailed series, which analyzes the registration data requirements and data exemption conditions for the simple and regular registration of polymers.
For polymers that do not meet the filing conditions, simple or regular registration is required according to the registration volume. Among them, if the annual production or import volume is more than 1 ton but less than 10 tons, a simple registration shall be handled; if the annual production or import volume is more than 10 tons, a regular registration shall be handled.
For regular registration or simple registration of polymers, in addition to the registration materials of general substances, information characterizing the polymers, residual conditions of monomers in polymerization reactions, and conditions of metals or cations contained therein shall be submitted. Polymers that meet the data exemption conditions can be exempted from submitting health toxicology, ecotoxicology data and environmental risk assessment reports.
Requirements for polymer registration materials
regular registration | simple registration |
(1) Application Form | (1) Application Form |
(2) Legal person certificate or business license, agency contract or agreement (with agent), power of attorney (with authorization) | (2) Legal person certificate or business license, agency contract or agreement (with agent), power of attorney (with authorization) |
(3) Test report or data a | (3) Test report or data a |
(4) Description of the necessity of information protection (such as applying for information protection) | (4) Description of the necessity of information protection (such as applying for information protection) |
(5) Commitment to implement or transmit environmental risk control measures and environmental management requirements | (5) Commitment to implement or transmit environmental risk control measures |
(6) Test organization condition data | (6) Test organization condition data |
(7) The information B characterizing the polymer identification, the residual situation of the polymerization monomer, and the situation of the metal or its cation. | (7) The information B characterizing the polymer identification, the residual situation of the polymerization monomer, and the situation of the metal or its cation. |
(8) Environmental risk assessment reporta | (8) The conclusion and basis for the determination of persistence, bioaccumulation and toxicity; |
(9) Social and economic benefit analysis report (high hazard) | (9) Other information on the environmental and health hazard characteristics and environmental risks of the application substance. |
(10) Other information on the environmental and health hazard characteristics and environmental risks of the application substance; |
a After judging by the nature of the substance, the corresponding report or information may be exempted if the data exemption conditions are met;
B Information characterizing polymer identity: including monomer/reactant list, molecular weight distribution map and polymerization reaction mechanism process.
Data exemption conditions:
Polymers that meet the following three conditions at the same time may be exempted from submitting health toxicology, ecotoxicology data and environmental risk assessment reports for simple or regular registration.
Waiver Conditions | |
1 | The structure does not contain other metals except sodium, magnesium, potassium and calcium; |
2 | Insoluble in water, lipophilic solvents (n-octanol, n-heptane) and common solvents (tetrahydrofuran, dimethylformamide) |
3 | It is stable under acid-base conditions, I .e. stability tests at pH 4.0,7.0,9.0 and 1.2 (if physiologically important) |
The acceptance, review and approval procedures for simple and regular registration of polymers are the same as those for general substances. The time limits for acceptance and approval are 5 and 20 working days respectively (10 working days can be extended with the approval of the person in charge of the competent department). The review time limit is 30 days for simple registration and 60 days for regular registration. The time for supplementary materials of applicants at all stages is not included in the time limit. After the approval, the corresponding production or import activities can be carried out.
The series of explanations on polymers are all completed. If you have any other questions, please feel free to contact us. We will provide you with professional new chemical substance registration consulting services.
The following is a previously released explanation on the registration of new polymer substances-series 1, for your reference:
New polymer substance registration explanation-series one
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